Synthon B.V.

Overview

Synthon B.V. is a Netherlands-based pharmaceutical company that specializes in the development and manufacture of generic and biosimilar medicines. The company focuses on delivering high-quality, affordable medicines. Synthon B.V. aims to address unmet medical needs and improve patients' lives with its innovative products.

Therapeutic areas

API / Drug Master Files

Synthon B.V. holds 16 active (22 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• NUSINERSEN SODIUMActive2026-03-17
• SIPONIMOD ADIPIC ACIDActive2025-09-25
• VISMODEGIBActive2025-07-17
• IXAZOMIB CITRATEActive2025-01-30
• TIVOZANIB HYDROCHLORIDE MONOHYDRATEActive2024-09-10
• OZANIMOD HYDROCHLORIDEActive2023-11-23
• AXITINIBActive2023-02-02
• ENZALUTAMIDEActive2021-10-29
• PALBOCICLIBActive2020-04-14
• LENALIDOMIDEActive2020-03-27
• SUGAMMADEX OCTASODIUMActive2019-07-10
• VALSARTAN DISODIUMActive2019-03-07
• MIRABEGRONActive2018-02-02
• POMALIDOMIDEActive2016-08-02
• GEFITINIBActive2015-11-17

Showing 15 of 22 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Synthon B.V. in our records. PharmaTek screens the full directory against live FDA enforcement data.